Diffuse Coronary Artery Lesions
Conditions
Brief summary
The prospective, randomized, controlled clinical trial aims to evaluate the safety and efficacy of paclitaxel-eluting PTCA-balloon catheter (SeQuent® Please) combined with provisional spot stenting of DES versus DES for treating diffuse coronary artery lesions concerning interventional therapy and vessel patency.
Interventions
DEVICEdrug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES)
using drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES) for treating diffuse coronary artery lesions
DEVICEdrug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES)
using drug-coated balloon (DCB) combined with second-generation DES for treating diffuse coronary artery lesions
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient-related * Patients who have typical angina pectoris symptoms with obvious evidence of ischemia; * Patients whose ages are between 18-80 years; * Patients who must agree to receive a 9-month angiographic follow-up; * Patients who must agree to receive clinical follow-up of 30 days, and 3, 6, 9, 12, 24 and 36 months; * Patients who can understand the purpose of this study both psychologically and linguistically, demonstrating sufficient compliance to the study protocol; * Patients who express their recognition of the risks and benefits described in the informed consent form by providing their inform consent; * Lesion-related * Diffuse coronary artery disease in situ; * Reference target vessel diameter of 2.5-4.0 mm and length of \> 25 mm; * Non-target vessel lesions needing to receive a successful intervention therapy first before randomization to receive treatment for target lesions (note: within the same hospitalization); * Visually estimated diameter stenosis of ≥70%, or diameter stenosis of ≥50% with objective evidences of ischemia (treadmill exercise testing, ECT or FFR\<0.8)
Exclusion criteria
* Patient-related: * Patients who have the attack of myocardial infarction within the past week, or whose troponin fails to return to normal although myocardial infarction has occurred for over one week; * Patients with serious congestive heart failure or NYHA IV-level serious heart failure; * Patients whose left ventricular ejection fraction is \< 30%; * Patients who have medical history of stroke or TIA within 6 months prior to the surgery; * Patients who have a current or previous history of serious liver failure and thereby fail to meet the requirements of angiography; * Patients who have a current or previous history of serious kidney failure (GFR\<30 ml/min) and thereby fail to meet the requirements of angiography; * Patients who have a previous history of intracranial neoplasms, aneurysm, arteriovenous malformation or cerebral hemorrhage; * Patients whose life expectancy does not exceed 1 year or who are difficult to follow up clinically; * Patients who have been scheduled to undergo elective surgery which may lead to the early discontinuation of ADP receptor antagonists; * Pregnant or lactating women or women who are planning to become pregnant during the study. * Patients participating in any other clinical trial; * Patients who are considered not suitable for inclusion by the investigator for any other reason; * Lesion-related: * Patients who have the evidence of extensive thrombosis in target vessels prior to the interventional therapy; * Patients who have left main coronary artery disease or graft lesions needing to be treated; * Patients who have bifurcation lesions with a side-branch vessel diameter of \>2.5 mm; * Patients who have lesions at the ostia of coronary artery, at the circumflex branch, at the ostia of anterior descending branch or within 5 mm at the ostia of coronary artery; * Severe intimal tear disease; * In-stent restenosis; * Lesions which can not be treated with PTCA or other intervention technologies; * Lesions with serious calcification; * Concomitant medication related * Patients who have a physique prone to hemorrhage and are prohibited from taking anticoagulants or antiplatelet drugs; * Patients who can not tolerate Aspirin and/or Clopidogrel, or who have serious hypohepatia and must not use Clopidogrel; * Patients who can not tolerate or have known allergy to heparin, contrast media, paclitaxel, iopromide, rapamycin, poly(lactic-co-glycolic acid) polymers or stainless steel, etc,; * Patients with a history of leukopenia (with WBC\<3×109/L for more than 3 days), neutropenia (with ANC \<1,000 cells/mm3 for more than 3 days), or thrombocytopenia (with platelet count \<100,000/mm3);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late lumen loss | 9 months | Late lumen loss (LLL) in the lesion segment within 9 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interventional therapy success rate | 3 years | including device success rate, lesion success rate and clinical success rate |
| Restenosis rate (RR) in the lesion segment | 9 months | Restenosis rate (RR) in the lesion segment on 9 months after operation |
| Clinically-driven target lesion revascularization | 3 years | Clinically-driven target lesion revascularization (CD-TLR) at 30 days and 3, 6, 9, 12, 24 and 36 months postoperatively |
| Device-related cardiovascular clinical composite endpoints | 3 years | including cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization (CD-TLR), called target lesion failure (TLF) for short |
| Patient-related cardiovascular clinical composite endpoints | 3 years | including all-cause mortality, all myocardial infarctions, and any revascularization |
Contacts
Primary ContactGao Lei, MD
Outcome results
None listed